Phase 2 N=120 Randomized Single-blind Treatment

Blood Pressure After Endovascular Stroke Therapy-II

Acute Stroke · Endovascular Thrombectomy

Bottom Line

View on ClinicalTrials.gov: NCT04116112 ↗

Enrolled (actual)

120

Serious AEs

6.7%

Results posted

Oct 2023

Primary outcome: Primary: Final Infarct Volume — 46.4; 50.7; 32.4 Cubic Centimeters

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Nicardipine (Drug); Labetalol (Drug); Hydralazine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Cincinnati
Primary completion: Jul 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Final Infarct Volume	46.4; 50.7; 32.4	—
PRIMARY Utility-weighted Modified Rankin Score	0.58; 0.47; 0.51	—
SECONDARY Number of Participants With Any Hemorrhagic Transformation	12; 12; 14	—
SECONDARY Number of Participants With Symptomatic Hemorrhagic Transformation	2; 1; 2	—
SECONDARY Number of Participants With Neurological Worsening Associated With Antihypertensive Treatment	0; 0; 0	—

Summary

The purpose of this study is to assess the safety of lowering blood pressure in acute stroke patients that are successfully treated with a mechanical thrombectomy procedure. The investogators will evaluate the hypothesis that lower blood pressure management strategies do not result in larger volume of stroke or worse 3-month clinical outcome in these patients.

Eligibility Criteria

Inclusion Criteria

Adult patients (≥18 years)
Undergoing successful EVT (defined as modified Thrombolysis in Cerebral Ischemia Score, mTICI, ≥2b) for an occlusion in the anterior cerebral circulation large vessel (internal carotid artery and M1 or M2 segments of the middle cerebral artery).
Intervention will be initiated only for those with a successful recanalization (modified Thrombolysis in Cerebral Ischemia Score ≥ 2b).
Undergoing a baseline CT or MR perfusion study
Those with unsuccessful recanalization (mTICI 0-2a) will be not intervened upon.

Exclusion Criteria

Known heart failure with ejection fraction <30%
Presence of a left ventricular assist device
Patients undergoing extracorporeal membrane oxygenation
Pregnancy
Enrollment in any other clinical trial

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04116112). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.